An Eye Tracking Study of Affective Disorder Patients With Suicide Risk

NCT03711045 | Unknown

• 2 other identifiers: Second Xiangya hospital CSUMental Health Insititute
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This research tries to investigate the validity and reliability of eye-tracking technologies by using different paradigms (eg. free-view, pro-saccade and anti-saccade) which served as a novel way of evaluating suicide risk among affective disorder patients including bipolar and unipolar depression. All the participants including health control will be assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.

Conditions

Major Depressive Disorder; Bipolar Disorder; Suicide

Keywords

eye-tracking; eye movement; saccade

Outcome Measures

Primary Outcomes (1)

• eye movement performance during free-view task

  The first fixated location and latency(msec)of eah trial, the total dwell time(msec) in each interest areas(IAs) during the whole trial to assess the attentional bias in the experiment.

  1 hour

Secondary Outcomes (4)

• Scores in self-report assessment:Beck Depression Inventory

  5 minutes

• Scores in self-report assessment:Beck Anxiety Inventory

  5 minutes

• Scores in self-report assessment:Barratt Impulsiveness Scale

  5 minutes

• Scores in self-report assessment:Ruminative Response Scale

  5 minutes

Study Arms (3)

Suicide Risk Group

patients with affective disorders(eg. bipolar disorder, major depression disorder) also have a history of suicide attempt in the past 6 months.

Behavioral: eye-tracking

Disorder Control Group

patients with affective disorders(eg. bipolar disorder, major depression disorder) and without suicide ideation or behavior.

Behavioral: eye-tracking

Healthy Control Group

Behavioral: eye-tracking

Interventions

eye-tracking BEHAVIORAL

After completing a demographics form, theBeck Depression Inventory,Beck Anxiety Inventory,Barratt Impulsiveness Scale and Ruminative Response Scale-21, each participant has to go to the eye-tracking room and seats in a height adjustable chair and places their chin in a chin rest which was positioned to make sure all participants' eye are in the same location relative to the camera and the monitor. There are 18 trials and 2 filler trials in the free-view task, each of which contains 4 pictures on the same screen for 25 seconds. There is also a gap screen between each trial lasting for 2 seconds when participants were asked to fixate in the center of the screen. During the experiment, participants are instructed to watch the screen as naturally as possible, and the initial location of the fixation of each trial and the total dwell time of each emotional images(negative, happy, neutral and suicide-related)and the changes of the pupil size were recorded.

Disorder Control Group; Healthy Control Group; Suicide Risk Group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from outpatients in psychiatric clinic and clinical psychological clinic, and inpatients residing in the mental health hospital. Most of the healthy volunteers were recruited from the advertisement posters in community and medical college. There are two steps for screening. Firstly, each person was asked to complete the BDI (Beck Depression Inventory,21-items) to evaluate the depressive symptoms. Individuals with scores less than 13 and more than 20 were enrolled for this study. Secondly, each individual has to be taken for a structural diagnostic interview (MINI-International Neuropsychiatric Interview, M.I.N.I.6.0.) in order to diagnosis current disorder and evaluate suicide risk by a psychiatrist who had already clinical consistency training.

You may qualify if:

• Diagnostic and Statistical Manual,DSM-IV diagnosis of depression or Bipolar disorder
• BDI-II\>20(Suicide and disorder control group); BDI-II\<13，no history of depression(Health control)
• Informed consent
• suicide attempt in the past 6 months(suicide risk group)

You may not qualify if:

• Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
• History of epilepsy or head trauma
• Eye disorders
• History of electroconvulsive therapy in the past 4 weeks.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410001, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Suicide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Li Lingjiang, MD Ph.D.

CONTACT

+86 13807314575; LLJ2920@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Chinese Psychiatry Society of Chinese Medical Association

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 18, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)